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Establishment Labs Holdings Inc. earnings calls

ESTA · every analyst question and management's answer

Oct 29, 2026 earnings call — U.S. expansion and minimally invasive growth

Q3 revenue was $72 million and the company generated positive free cash flow of $5.1 million, its first quarter of positive free cash flow.

Revenue $0.1B (est $0.1B) · EPS $-0.35 (est $-0.26)

Key quotes

"Although we are regularly adding new accounts, our focus is increasingly on utilization within our existing base."

— Filippo Caldini (CEO) · U.S. utilization

"Our minimally invasive platform is an important growth driver, generating approximately $9 million in third quarter revenue, an increase of 124% year-over-year, fueled by our U.S. expansion."

— Filippo Caldini (CEO) · Minimally invasive platform

"Q3 marks our first quarter of positive free cash flow, a major milestone, and we are looking forward to our first year of positive free cash flow in 2027."

— Filippo Caldini (CEO) · Financial milestones

Analyst Q&A 13

international breast implant markets

Q (Michael Matson · Needham & Company): He asked if markets outside the U.S. showed any slowdown and whether the company was simply outperforming peers.

A: Management said outside-U.S. markets are generally stable with some exceptions like the Middle East. They highlighted strong performance in direct markets, with 16% growth this quarter and changes to distributor relationships to sustain growth into 2027.

"A big focus for us was on the direct markets, and we again had 16% growth this quarter." — Filippo Caldini (CEO)

minimally invasive seasonality

Q (K. Gong · JPMorgan): He asked why minimally invasive revenue stepped back in Q3 compared with Q1 and Q2 — seasonality or price sensitivity?

A: Management said the Q3 step-back was driven by seasonality, especially in Europe where Q3 is a weak season. They noted year-over-year growth remains strong and reminded investors they raised minimally invasive expectations to over $40 million.

"And so that's had an impact in terms of the level of procedures, not just within minimally invasive, but overall." — Filippo Caldini (CEO)

increase implant use per account

Q (Colin Clark · TD Cowen): He wanted to know how they will raise Motiva utilization above 43% among existing U.S. accounts and grow usage within practices.

A: Management said utilization rises over time as accounts work through schedules and adapt to the product. They are using sales force efforts and marketing; month-over-month average orders per account are increasing and they expect utilization to go up.

"When you look at month-over-month, the average orders per account continues to increase, and that's a good indication that we're increasing that utilization." — Filippo Caldini (CEO)

2027 margins and cash flow

Q (Matthew Taylor · Jefferies): He asked how to think about margins or cash flow in 2027 given the 25% revenue growth target.

A: Management said the 25% revenue target is supported by U.S. and minimally invasive growth and should allow further gross margin expansion. They expect 50 to 100 basis points of gross margin improvement in FY 2027, depending on geographic and channel mix.

"So ultimately, we believe the 50 to 100 basis points for FY 2027, and that will be dependent somewhat on geographic and channel mix." — Cassandra Harris (CFO)

commercial investments to boost use

Q (Sam Eiber · BTIG): He asked what investments — sales reps or direct-to-consumer — are planned to raise utilization in existing accounts.

A: Management said the key investment is adding sales reps and leadership to drive utilization; they have increased reps to 55 and added leadership roles. They will continue targeted marketing investments in certain accounts and are already seeing impact.

"In terms of the investment, it's really about the additions to our sales force." — Filippo Caldini (CEO)

quarter gross margin drivers

Q (Joseph Federico · Stifel): He asked for detail on quarter gross margin, the effect of geographic and distributor mix, and implications for Q4 and the U.S.

A: Management said adjusted gross margin was 70.8% in Q3, driven by growth in the higher-margin U.S. business which rose from 22% to 35% of revenue. They said stronger OUS distributor contribution (60% of OUS vs planned 50%) lowered the percent, and with three quarters done a Q4 favorable mix would have limited full-year impact, but they still see 50 to 100 basis points available going forward.

"That really does reflect the growth of the higher-margin U.S. business, which increased from 22% last year to 35% this year." — Cassandra Harris (CFO)

new implant sizes and recon process timing

Q (Anthony Petrone · Mizuho Group): He asked how much U.S. market the new smaller implant sizes open and how many hospital VAC committee processes they expect for reconstruction.

A: Management said the newly approved smaller sizes represent about 10% of the market and will open a meaningful opportunity and help utilization. They noted Flora is already in about 350 hospitals but reconstruction still requires VAC processes that can take about 3 to 6 months; they are building capabilities to accelerate that timing.

"What we've historically said, it represents about 10% of the market." — Filippo Caldini (CEO)

commercial build for reconstruction

Q (Caitlin Cronin · Canaccord Genuity): She asked if they are already building commercial capabilities for entering reconstruction and about competitive dynamics.

A: Management said they have started building commercial capabilities, increased reps to 55 and expect to keep expanding the sales team. They have added leadership roles and internal capabilities specifically to address hospital network requirements and are investing because they see opportunity in the short term.

"We've also built out some of the leadership position, specifically to address the requirements for the hospital network." — Filippo Caldini (CEO)

reconstruction approval timing

Q (Citi): He asked when they expect reconstruction approval and whether recent clinical inspections are the final step.

A: Management said the approval process is progressing as expected: they have submitted FDA responses, undergone the BIMO inspection, and had the sponsor site visit. They cannot predict FDA timing but said they are confident and expect approval in the near term, likely at the end of this year or the beginning of next.

"But we're very confident that we are in a very good position to get that approval, and we can never predict the timing of the FDA, but we're confident that, that's going to be in the near term." — Filippo Caldini (CEO)

how many hospitals drive recon volume

Q (Mason Carrico · Stephens): He asked how many U.S. hospitals/centers perform meaningful implant-based reconstruction and how much volume is in facilities already using Flora.

A: Management said about 130 U.S. hospital accounts drive the majority of reconstruction volume. Flora has given them entry into many of those accounts, but some hospitals will wait for the full reconstruction indication before adopting the implant suite.

"So what we see in terms of the real volume in terms of the number of accounts in the U.S. is probably close to 130 accounts in the U.S." — Filippo Caldini (CEO)

does 25% guidance include recon

Q (Anthony Petrone · Mizuho Group): He asked whether the 25% 2027 guide already includes reconstruction or if reconstruction is upside.

A: Management said the 25% outlook reflects confidence in Motiva, minimally invasive, utilization gains, and market share growth and that reconstruction is an important long-term opportunity. They believe regulatory timing remains aligned with expectations later this year or Q1 next year, and a bulk of reconstruction revenue would come in the back half of the year.

"So our 2027 outlook reflects our expectations for our business as a whole, including the opportunities across our portfolio." — Cassandra Harris (CFO)

distributor order timing internationally

Q (Colin Clark · TD Cowen): He asked if distributor strength caused any international pull-forward and whether that affected guidance.

A: Management said distributor order timing is variable; they showed 14.4% growth in Q1, 4.4% in Q2, and 10% in Q3 and remain confident in mid-single-digit growth for the year. They are working with distributors to align orders closer to market demand with more make-to-order programs and expect patterns to follow prior behavior.

"We've also been working with our distributors to get those orders closer to the demand in the market." — Cassandra Harris (CFO)

NuSil contract and silicone cost impact

Q (Michael Matson · Needham & Company): He asked if the new NuSil agreement has an inflationary adjustment not in the prior agreement, whether costs could rise, and how much of COGS is silicone.

A: Management said the new contract is business as usual and reflects similar pricing terms and volume tiers as the prior contract, so they do not expect a major impact. They added that if inflationary cost increases occur they would look to pricing to help offset margin pressure and view the contract as relatively consistent with past terms.

"And as we've talked about in our margins is that we do expect that any type of inflationary increases, we would look to pricing to help offset some of that margin as well." — Cassandra Harris (CFO)

AI-generated notes on the earnings call transcript. Quotes are taken from the transcript. This is not a FolioObs investment view.

Establishment Labs Holdings Inc. (ESTA) · Earnings calendar

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